Medication errors, such as Preventable Adverse Drug Reaction Events (ADE's), commonly occur in hospitals and in emergency care situations, and often have tragic consequences. Such errors include administration of the wrong drug, drug overdoses, and overlooked drug interactions and allergies.
More than one million serious medication errors occur every year in U.S. hospitals alone. According to a 1999 Institute of Medicine (IOM) report, medication errors alone contribute to 7,000 deaths annually. Medication errors also result in approximately 250,000 non-fatal injuries each year (Harvard Medical Practice Study). Preventable injuries caused by adverse reactions to drugs increased hospital costs by US$4,700 per admission (Journal of the American Medical Association) in the United States. Furthermore, this figure excludes other important costs of medication errors, such as malpractice insurance premiums, and losses in worker productivity.
One common cause of medication errors is poor identification of syringes in which medication has already been drawn-up. Prepared dosages, already drawn up into syringes, are used often in medical emergency situations and also in timetabled events such as surgery, where trays of medication needed over the course of the surgery are prepared before the surgery begins and are laid out on trays.
Of all medications, intravenous medications are one of the most difficult medications to identify once they have been drawn up into a syringe. Almost all intravenous medications appear as a clear liquid when viewed through a syringe sidewall with virtually no way of distinguishing between medications once drawn up.
It is therefore desirable for the ampoule from which the medication was drawn to be placed with the syringe, so that the type and/or intended dosage of medication can be ascertained, if necessary, from the label on the ampoule. It is common practice for an ampoule to be affixed directly onto a syringe using adhesive tape. (For example, the Queensland Ambulance Service Clinical Practice Manual instructs its members to use adhesive tape to attach the used glass ampoule to the syringe.) This practice has the disadvantage that the measurement indicators (dose markers) on the syringe body are often obscured, affecting the user's ability to read the dosage that has been drawn up into the prepared syringe. The portion of the label facing the syringe is also obscured. Another disadvantage of using adhesive tape to attach a used ampoule to the syringe is that the exposed jagged broken neck of the ampoule poses a risk of a sharps injury.
U.S. Pat. Nos. 5,290,261 and 2,627,269 each disclose clips for mounting an ampoule to a syringe. The device of U.S. Pat. No. 5,290,261 includes a socket that receives an ampoule, and a ring that surrounds the syringe. The socket and associated ring will only fit one size ampoule and syringe. The device of U.S. Pat. No. 2,627,269 has a basket that holds an ampoule. Again, the basket is designed for a particular size of ampoule. This device also has a relatively complex metal construction, and is therefore expensive to manufacture.
International patent application PCT/GB2004/003135 (WO 2005/011781) discloses a medical needle system having two cylinders. One cylinder is used to store the body of the syringe, and the other cylinder receives both a needle assembly and vial or ampoule. This system also has the disadvantage that it is intended for use only with syringes and vials of predetermined diameters. It is also relatively complex and therefore expensive to manufacture.
US patent application no. 2002/0083564 describes a clip for securing a vial to a syringe. The integrally formed flexible plastic clip comprises two juxtaposed c-shaped clips joined by a bridge, each clip being adapted to be snap-fitted to a syringe and vial, respectively. Yet again, the clip is intended for use only with syringe and vial of a predetermined size.
A serious disadvantage of all the prior art clips described above is that the portions of the clips which hold or secure the ampoule obscure the label on the ampoule to some degree. This renders it difficult, if not impossible, to read the label while the ampoule is attached to the syringe, and therefore increases the risk of administering the wrong drug or the wrong dosage.